OTC Medication Information: Bismuth Subsalicylate

BISMUTH SUBSALICYLATE- bismuth subsalicylate capsule, gelatin coated
TOPCO ASSOCIATES LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient ( in each softgel) Purpose

Bismuth subsalicylate 262 mg …………….Upset stomach reliever and anti-diarrheal

Uses

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching
  • fullness

Warnings

Reye’s syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an
early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product

  • a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • swallow with water, do not chew
  • adults and children 12 years and over:
  • 2 softgels every ½ hour or 4 softgels every hour as needed for
    diarrhea
  • 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset
    stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 softgels) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by
    diarrhea

Other information

  • each softgel contains: salicylate 102.33 mg
  • very low sodium
  • do not exceed 25°C

Inactive ingredients

aerosil, beeswax, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Stomach Relief

BISMUTH SUBSALICYLATE 262 mg
Upset stomach reliever/Antidiarrheal

Soothing relief for 5 symptoms:
• Heartburn
• Indigestion
• Upset stomach
• Nausea
• Diarrhea

24 SOFTGELS

TR SR
(click image for full-size original)
BISMUTH SUBSALICYLATE
bismuth subsalicylate capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-710
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LECITHIN, SOYBEAN
YELLOW WAX
CARBOXYMETHYLCELLULOSE SODIUM
LIGHT MINERAL OIL
GELATIN
GLYCERIN
D&C RED NO. 33
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
WATER
Product Characteristics
Color pink Score no score
Shape OVAL (Oblong shaped) Size 21mm
Flavor Imprint Code 262
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-710-24 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the CARTON (36800-710-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 02/19/2021
Labeler — TOPCO ASSOCIATES LLC (006935977)

Revised: 09/2021 TOPCO ASSOCIATES LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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